InjuryLQZ
NARVAL CC ORTHESE MRD
Received Jul 30, 2014
Report 3004604967-2014-00018 · MDR key 4039863
Device
Manufacturer
Resmed SasProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
THE DENTIST RETURNED THE DEVICE AND THE ORIGINAL MODELS OF THE PT'S TEETH. THE RETURNED DEVICE FIT THE ORIGINAL TEETH MODEL THAT WAS USED TO FABRICATE THE DEVICE. THE INFO PROVIDED BY THE REPORTER INDICATES THAT THE PT HAD AN EXISTING DENTAL CONDITION. THIS CONDITION MAY HAVE BEEN EXACERBATED BY THE USE OF THE MANDIBULAR DEVICE AND LED TO THE PT'S TOOTH REMOVAL.
Description of Event or Problem
IT WAS REPORTED TO RESMED RMT THAT THE NARVAL CC MANDIBULAR REPOSITIONING DEVICE CONTRIBUTED TO A TOOTH LOSS.